Medical Device Division · registration 100436Expired

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 100436
Creator: St. Jude Medical, Cardiac Rhythm Management Division
Keywords: St. Jude Medical, St. Jude Medical, 100436, Leads, Pacemaker, Implantable, Endocardial, Medical Device Division

Hong KongLeads, Pacemaker, Implantable, EndocardialClass IVSt. Jude Medical, Cardiac Rhythm Management Division

Verified

Official record identity

MDACS listing number: 100436
Model name: IsoFlex S (1642T, 1646T)
Registration date: November 26, 2010
Expiry date: November 26, 2015
Source update date: October 25, 2024
Status: Expired

Classification

Risk class: Class IV
Published category: Leads, Pacemaker, Implantable, Endocardial

Published parties

Registrant / registration holder: Abbott Medical (Hong Kong) Limited
Manufacturer: St. Jude Medical, Cardiac Rhythm Management Division

Official description

Leads, Implantable Cardiac Pacemaker, Endocardial

Additional source fields

AMD nomenclature code: 12900
Traditional Chinese local responsible person: 美國雅培醫療用品(香港)有限公司
Local responsible person phone: 29967688
Published manufacturer address: 15900 Valley View Court, Sylmar, CA 91342, USA
Published remarks: Expired.
Revision number: a

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.